Kornimate/medical-research-clean huggingface dataset:
a phase ii trial of perioperative chemotherapy with oxaliplatin, 5-fluorouracil, leucovorin(modified folfox6) in patients with locally advanced operable gastric cancer

Conditions: Advanced Gastric Cancer

Summary: the role of perioperative chemotherapy in potentially operable advanced gastric cancer (agc) with regional lymph node metastasis is still in the area of controversy. the aim of this study is to evaluate the efficacy and toxicity of folinic acid (fa), infusional 5-fluorouracil (5-fu), and oxaliplatin (modified folfox6) in potentially resectable agc with regional lymph node (ln) metastasis.


Eligibility criteria:
inclusion criteria: * previously untreated patients with pathologically proven advanced gastric adenocarcinoma with regional ln metastasis (clinical stage: ct2-4 and n+) * at least one measurable regional lymph node metastasis according to the response evaluation criteria in solid tumors (recist v. 1.0) * age between 18 and 75 years * eastern cooperative oncology group performance status (ecog ps) of 0 or 1 * no prior chemotherapy or radiotherapy * adequate bone marrow, hepatic and renal function (absolute neutrophil count \[anc\] ≥ 1.5ⅹ109/l, platelet count ≥ 100ⅹ109/l, total bilirubin ≤ 1.5ⅹupper limit of normal \[uln\], serum transaminases ≤ 2.5ⅹuln, alkaline phosphatase ≤ 2.5ⅹuln, serum creatinine ≤ 1.5ⅹuln or actual or calculated creatinine clearance ≥ 50 ml/min). exclusion criteria: * clinical stage t1 tumors * clinical or radiologic evidence of distant metastasis * intestinal obstruction or impending obstruction * active tumor bleeding * interstitial pneumonitis or symptomatic pulmonary fibrosis * peripheral neuropathy of national cancer institute common toxicity criteria (nci-ctc) grade ≥1 * pregnant or breastfeeding patients * other serious diseases
gemcitabine in combination with cisplatin as neoadjuvant nsclc chemotherapy

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: to evaluate the clinical response rate of neoadjuvant chemotherapy with gemcitabine and cisplatin in patients with operable nsclc


Eligibility criteria:
inclusion criteria: * histologic or cytologic diagnosis of operable non-small cell lung cancer (ib-iiia) * no prior chemotherapy * who criteria for disease status assessment exclusion criteria: * concurrent administration of any other tumor therapy * pregnant or breast feeding * serious concomitant disorders
etravirine plus 2 analogs in hiv-infected patients

Conditions: HIV-1-infection

Summary: the purpose of this study is to evaluate the virological and clinical efficacy of etravirine plus 2 active nucleos(t)ide reverse-transcriptase inhibitors (nrtis) in hiv-infected patients. additionally, the safety of these regimens, specially lipid profiles, will be assessed.

methods: prospective, single arm multicenter clinical trial without entry restrictions on plasma hiv-rna (vl) or cd4 with a planned duration of 52 weeks. the primary clinical endpoint is the percentage of subjects with therapeutic success on etravirine 400 mg/day (200 mg bid or 400 mg qd) plus 2 active nrtis after 12 months. efficacy data will be analyzed by on-treatment and by intention-to-treat analyses (noncomplete/missing equals failure), considering treatment failure as either treatment interruption whatever the reason (adverse events, death, or loss to follow-up) or virological failure, defined as inability to suppress the vl to less than 50 copies/ml after 24 weeks on treatment or a confirmed vl of more than 200 copies/ml in patients who had previously achieved a viral suppression or had an undetectable viral load at inclusion. patients missing two consecutive scheduled visits were considered lost to follow-up. the safety and tolerability of the studied medications will be evaluated by means of clinical adverse events, physical examination and laboratory results. nrtis prescribed as part of haart were selected by the responsible physicians on the basis of previous antiretroviral treatments and/or genotypic resistance testing.

Eligibility criteria:
inclusion criteria: * older than 18 years, starting an antiretroviral regimen based on etravirine plus 2 nrtis between january 2009 and june 2010, evidence of activity of all drugs on the basis of treatment history and genotypic resistance testing, informed consent, and at least one follow-up visit. exclusion criteria: * genotypic resistance tests with evidence of resistance to any drug used, and concomitant use of drugs with potentially adverse interactions with etravirine pharmacokinetics, such as rifampin.

Keywords: hiv-infection etravirine treatment non-nucleoside reverse-transcriptase inhibitor
register of patients with haemophilia a treated with afstyla®

Conditions: Haemophilia A

Summary: record real life data of patients with hemophilia a and treated with afstyla® to assess the effectiveness and the safety of the treatment used as prophylaxis, prevention of bleeding (e.g. surgery) or on-demand treatment during 3 years after patient inclusion

haemophilia a is a congenital coagulation disorder caused by a deficiency or abnormality of coagulation factor viii (fviii). the severity of the haemophilia depends on the magnitude of the fviii deficiency and the clinical features depend on the site of the bleed. the therapeutic management of this disease involves administering the deficient factor, fviii to the patient. depending on the severity of the disease and patient background, the management regimens are different (long term prophylactic treatment to prevent non surgical bleeds, prophylactic short term treatment to prevent surgical bleeds or treatment of acute bleeds on demand). several recombinant or plasma derived treatments are currently available. the csl behring company has designed a new recombinant single chain b1fviii, rfviii (afstyla®). this has increased affinity for vwf, resulting in improved stability and an improvement in its pharmacokinetic indices. opera is a non-interventional, prospective and national study which aim is to record real life data in haemophilia a french patients treated with afstyla® in order to confirm the efficacy and safety of this proprietary product established in clinical development studies.

Eligibility criteria:
inclusion criteria: * have given their agreement to take part in the observational registry after being informed in writing of the purposes of the study and after their data have been recorded (parent's agreement for minor patients); * be suffering from haemophilia a and being treated or having been treated with afstyla® long term prophylactically, on demand or preventatively for a surgical procedure; * absence of inhibitor and/or treatment for immune tolerance at the time of inclusion exclusion criteria: * refusal of the patient or the patient's legal representative to take part in the study; * existence of a contraindication to the use of afstyla® treatment (known hypersensitivity to fviii or hamster proteins); * simultaneous participation in an interventional clinical study. * presence of an inhibitor and/or ongoing immune tolerance.

Keywords: fviii coagulation fviii
elidel-study: elidel in patients with atopic dermatitis

Conditions: Atopic Dermatitis

Summary: atopic dermatitis is a common disease. emollients and elidel have both shown to be effective to treat this disease. the research question is, whether the effective component (elidel) is better than the emollient to improve the skin function.


Eligibility criteria:
inclusion criteria: * age \> 18 years * atopic dermatitis on both lower arms at least 1% body surface area. * atopic dermatitis severity index (adsi)-score \>= 6 * investigator global assessment (iga)-score \>= 2 exclusion criteria: * systemic therapy with immunosuppressive drugs within the past 24 weeks * phototherapy against atopic dermatitis. * antibiotic therapy against atopic dermatitis. * allergy against elidel. * pregnancy * nursing * skin cancer

Keywords: atopic dermatitis on both lower arm.
effectiveness analysis of active stretching versus active stretching with low frequency currents

Conditions: Muscular Diseases

Summary: the purpose of this study is to determine whether active stretching with low frequency currents are more effective than active stretching in the treatment of hamstring shortness syndrome in children.

in 2012 we studied 51 young footballers with short hamstring syndrome in spain. three groups were formed: 1. stretching+transcutaneous electrical nervous stimulation (tens); 2. active stretching; 3. conventional stretching. parameters: straight leg raise test (slr), popliteal angle with the passive knee extension test (pke) and the toe-touch test (tt). the inter-group means were compared and clinically relevant parameters calculated \[relative risk (rr), absolute risk reduction (arr), relative risk reduction (rrr) and number needed to treat (nnt)\].

Eligibility criteria:
inclusion criteria: * children between 10 to 16. * children federated belonging to football school of jumilla. * children whose result in the assessment of range of motion is less than 70º in the straight leg raising test. * not afraid to present the application of electrotherapy. * not have low back pain in last three months. * not to be injured exclusion criteria: * children who have acute muscle injury or ligamentous. * children with recent fractures or unconsolidated. * children with ligamentous laxity. * functional shortening suffering children

Keywords: young adult muscle stretching exercises range of motion, articular
efficacy and safety of conan® proctological cream for treatment of haemorrhoidal disease

Conditions: Hemorrhoid Pain; Haemorrhoid Inflammation

Summary: aim of the study is to assess the efficacy, safety and tolerability of conan® (proctological cream, medical device, omikron italia srl) on most frequent symptoms in grade 1-2 of haemorrhoidal disease and anal fissures.

background: to evaluate the role of conan® proctological cream containing escin, hesperidin and hyaluronic acid in topical treatment of haemorrhoidal disease and anal fissures and its potential efficacy in reducing related symptoms. methods: forty patients with haemorrhoidal disease and anal fissures were enrolled. of them, 20 were randomized to receive the medical device conan® cream (group a) and 20 to the untreated control group (group b). at each scheduled visit, total symptoms were assessed and recorded by assigning a numerical rating scale score from 0 to 10. the adverse events reported by study subjects were also assessed and recorded.

Eligibility criteria:
inclusion criteria: * aged between 18 and 70 years * hemorrhoidal pathology, anal fissures and anitis * nrs score ≥ 3 for at least one of the symptoms (burning, itching, feeling of heaviness, foreign body) exclusion criteria: * known hypersensitivity to study products * proctitis * current therapy with other local treatments based on phlebotropes and/or anti-inflammatories * surgical treatments undergone less than a year after inclusion * pregnancy, breastfeeding

Keywords: haemorrhoids; anal fissures; controlled clinical trial.
evaluation of maraviroc intensification in hiv infected patients with insufficient immune restoration

Conditions: HIV Infection; HIV Infections

Summary: this pilot study aims to evaluate maraviroc intensification strategy during 24 weeks in hiv infected patients under efficient (cv\< 50 cp/ml), controlled antiretroviral therapy (≥ 6 months) and uncompleted immune restoration (cd4\<350 cells/ml and cd4 earning \<100 cells/ml during last 24 months). the study will include 60 patients whose follow up is carried out for 48 weeks. recruitment period will be maintained for 12 months.


Eligibility criteria:
inclusion criteria: * hiv-1 infection * maraviroc-naives patients * cd4 less than 350 cells/mm3 * viral load less than 50 cp/ml and cd4 earning less than 100 cells/mm3 during last 24 months exclusion criteria: * hiv-2 infection * x4 tropism at inclusion * pregnancy and breast feeding * interferon, immunomodulatory drugs treatment or anti-hiv vaccines and chemotherapy * hypersensibility of peanut or soya

Keywords: maraviroc immune restoration treatment intensification
bortezomib/adriamycine/melfalan/prednisone (vamp)/thalidomide/cyclophosphamide/dexamethasone (tacydex) or bortezomib/melfalan/prednisone (v-mp)/tacydex) in refractary or relapsed multiple myeloma

Conditions: Multiple Myeloma

Summary: multicentric study, open, single arm, designed to evaluate the efficacy(response rate and response duration) and security of a sequential scheme of treatment with bortezomib in combination with melfalan and prednisone (v-mp) (patients \> 75 years) or bortezomib and adriamycine in combination with melfalan and prednisone (vamp) (patients \<= 75 years) follow by thalidomide in combination with cyclophosphamide and dexamethasone (tacydex) in patients with refractary or relapse multiple myeloma.

multicentric study, open, single arm, designed to evaluate the efficacy(response rate and response duration) and security of a sequential scheme of treatment with bortezomib in combination with melfalan and prednisone (v-mp) (patients \> 75 years) or bortezomib and adriamycine in combination with melfalan and prednisone (vamp) (patients \<= 75 years) follow by thalidomide in combination with cyclophosphamide and dexamethasone (tacydex) in patients with refractary or relapse multiple myeloma.

Eligibility criteria:
inclusion criteria: * patients with refractary or relapsed multiple myeloma * ecog ≤ 3 * life expectancy \> 3 months * neutrophils account ≥ 0.5 x 10\^9/l, platelets ≥ 30 x 10\^9/l. * transaminases \<3 times upper normal limit, bilirubin \< 2 times upper normal limit * age \> 18 years * time after last chemotherapy or radiotherapy \> 1 month or time after transplantation \> 2 months. * no possible other actual treatment * written consent form exclusion criteria: * candidate to second transplantation * no following criteria * other neoplasties * peripheral neuropathy \> grade 2. * previous ileus paralytic * hepatic failure * no controlled infection * no controlled high calcium levels * any organic insufficiency that no permit follow the correct treatment * pregnancy, breast feeding or fertility without anticonceptive method * any psychological, social and/or familiar event that no permit follow the correct treatment * diabetes mellitus not controled

Keywords: multiple myeloma relapsed refractary
a 12 week treatment, multi-center, randomized, double-blind, parallel-group, placebo and active controlled study to assess the efficacy, safety, and tolerability of indacaterol maleate / glycopyrronium bromide in copd patients with moderate to severe airflow limitation.

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: this study will assess the efficacy, safety and tolerability of qva149 in patients with moderate to severe airflow limitation.

note: detailed description: data not entered

Eligibility criteria:
inclusion criteria: * male and female patients that have signed informed consent and are \>/= 40 years of age. * patients with stable copd according to gold 2011. * patients with a post-bronchodilator fev1 of \>/= 30% and \< 80% predicted and a post-bronchodilator fev1/fvc \<0.70. * current or ex-smokers who have a smoking history of at least 10 pack years. * patients with an mmrc grade 2 or greater. exclusion criteria: * patients with type i or uncontrolled type ii diabetes - patients with a history of long qt syndrome or whose qtc measured at visit 101 (fridericia method) is prolonged (\>450 ms for males and females) and confirmed by a central assessor. (these patients should not be re-screened.) * patients who have a clinically significant ecg abnormality at visit 101 or visit 102. (these patients should not be re-screened.) * patients with a history of malignancy of any organ system, treated or untreated, within the last five years. * patients with narrow-angle glaucoma, bph or bladder-neck obstruction or moderate-severe renal impairment or urinary retention. * patients who had a copd exacerbation within 6 weeks prior to screening. * patients who have a respiratory tract infection within 4 weeks prior to screening. * patients requiring long term oxygen therapy prescribed for more than 12 hr per day. * patients with a history of asthma. 8. patients with an onset of respiratory symptoms, including copd diagnosis, prior to age 40 years. * patients with a blood eosinophil count of greater than 600 mm/3 during run-in. * patients with concomitant pulmonary disease. * patients with a diagnosis of alpha-1 anti-trypsin deficiency. * patients with active pulmonary tuberculosis. * patients in the active phase of a pulmonary rehabilitation programme. * other protocol-defined inclusion/exclusion criteria may apply

Keywords: copd, qva149
the efficacy and safety of agomelatine in the patients with parkinson's disease

Conditions: Parkinson Disease; Depression; Sleep Disorders; Circadian Rhythm Disorders

Summary: among the patients with parkinson's disease, about 40%\~50% will suffer from depression, 40% will suffer from anxiety, and 40%\~60% will suffer from sleep disorder. these non-motor symptoms of parkinson's disease will cause great physical and psychological pain and affect the quality of life seriously. commonly used therapeutic drugs, such as selective serotonin reuptake inhibitor (ssri) and clonazepam, can cause a variety of side effects, including serotonin syndrome, sexual dysfunction, daytime fatigue, insomnia, residual effects and increased risk of falls. therefore, a new and more reasonable therapeutic choice should be sought. agomelatine is a new type of antidepressant with novel mechanism, and can improve sleep structure and circadian rhythm. the aim of this multi-center randomized controlled trial (rct) is to clarify the role of agomelatine in improving sleep disorders and depression in patients with parkinson's disease


Eligibility criteria:
inclusion criteria: * diagnosed as parkinson's disease conforming to 2015 international movement disorder society(mds) diagnostic criteria * hoehn-yahr ≤ 3 at "open" stage * mini-mental state examination(mmse) ≥ 24 points; * pittsburgh sleep quality index (psqi) \> 7 points; * hamd-17 \> 13 points * pramipexole hydrochloride tablets 0.75mg / d (0.25mg tid) has been used stably for one month * signed informed consent exclusion criteria: * parkinson's syndrome and parkinsonism-plus syndrome * parkinson's movement symptoms are still fluctuating or the treatment of parkinson's movement symptoms is unstable * hepatitis b virus carriers/patients, hepatitis c virus carriers/patients, patients with impaired liver function or elevated transaminase levels above the upper limit * other serious neurological diseases, mental illnesses and physical illnesses * history of alcohol and drugs dependence * dementia * combined treatment with cyp1a2 strong inhibitor (fluvoxamine, ciprofloxacin, rifampicin, amiodarone, mexiletine, atazanavir, etc.) * high suicide risk or suicide attempt within 6 months (third item of hamd-17 ≥ 3) * antidepressant medication or other psychiatric treatment in the past month * pregnant or lactating * intolerance or allergy to agomelatine active ingredients and excipients * other conditions that are not suitable for the study considered by the investigators
the efficacy of multisession mindful breathing in symptom reduction among patients with advanced cancers

Conditions: Advanced Cancer

Summary: the goal of this clinical trial is to determine the efficacy of multisession mindful breathing in reducing symptoms among patients with advanced cancer. adult patients with advanced cancer will be assessed using edmonton symptom assessment system (esas) scoring system. patients who scored ≥4 in at least two or more components in esas will be recruited and randomly assigned to either 4 daily-session of 30-minute mindful breathing and standard care or standard care alone.

patients with advanced cancer admitted to the medical and surgical wards of ummc were consecutively approached to screen for eligibility. the 30-minute mindful breathing of the intervention group was guided by similar investigators for four consecutive days. these investigators were medical doctors who had been trained by the primary investigators - a palliative care physician and a certified mindfulness trainer. each session used different scripts and was conducted in the languages that were preferred by the patients (such as malay, english, or mandarin). briefly, patients were primed with knowledge of the gist of each script before being instructed to relax their bodies, close their eyes, pay attention to their breathing, and follow the guidance given. if they noticed any distractions, they were told to redirect their attention back to their breathing. patients in the control group only received standard care and were assessed at the same time of the day by similar investigators for four consecutive days. patients were allowed to continue their usual activities during each session.

Eligibility criteria:
inclusion criteria: * ongoing stage iiii-iv cancer, and a score of four or more in at least two components exclusion criteria: * impaired cognition or conscious level, as well as psychiatric illnesses that prevent them from giving informed consent or participating fully in the study

Keywords: mindful breathing, multisession, advanced cancers
comparing different ways of delivering humidity to children with croup

Conditions: Croup

Summary: croup affects 5% of children under 6 years of age, resulting in visits to hospital emergency departments, and in 1% of children, hospitalization. traditionally, the first therapy offered is humidification which can liquify airway secretions and decrease airway swelling. this study will compare the effectivenesss of 40% and 100% humidity through a specially designed machine called a nebulizer, with the usual humidity set-up (blown into the patient's face from a hose).


Eligibility criteria:
inclusion criteria: * children aged 3 months - 10 years * croup score greater than or equal to 2 after a 30 minute waiting period exclusion criteria: * symptoms of croup requiring immediate intervention with nebulized epinephrine or intubation * symptoms or signs of alternative causes of stridor * inability of caregivers to understand or speak english and/or sign for informed consent * history of chronic pulmonary disease except for asthma, or co-existent systemic disease * previous history of intubation * duration of present illness \>1 week * systemic or inhaled glucocorticoids in previous 48 hours * epinephrine in previous 4 hours

Keywords: croup humidity therapy pediatrics
trauma intervention for affect regulation, aids, and substances

Conditions: Human Immunodeficiency Virus; Substance Related Disorder; Post Traumatic Stress Disorder

Summary: the purpose of this study is to see if it is possible to deliver an intervention that targets trauma, substance use, and engagement in hiv care with hiv-positive women.


Eligibility criteria:
inclusion criteria: * hiv positive * woman or trans woman * substance use * elevated ptsd symptoms * hiv care difficulties exclusion criteria: * not hiv positive * no substance use * men * no hiv care difficulties * no history of trauma

Keywords: substance use trauma hiv viral load women